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Gastroenterology, Urology

11,291 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
SPARCO SCOPE GUARD (K850268)Sparco, Inc.1985-04-15
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER (K851162)Van-Tec, Inc.1985-04-15
PACKETS FOR PREP. OF DIALYSATES & INFUSATES - (K851188)Organon Teknika Corp.1985-04-12
OMNI PHASE PENILE PROSTHESIS (K850019)Dacomed Corp.1985-04-09
}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR (K850167)Urologics, Inc.1985-04-09
URETERAL DILATION SET (K851144)Van-Tec, Inc.1985-04-09
GAMBRO PRESSURE MONITOR GUARDS (K851230)Gambro, Inc.1985-04-09
COMPACT EXCHANGE DEVICE 5C4197 (K851208)Travenol Laboratories, S.A.1985-04-08
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 (K851207)Travenol Laboratories, S.A.1985-04-08
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- (K850865)Erika, Inc.1985-04-03
URETERAL DILATOR & URETERAL STONE DISLODGER (K850954)American Edwards Laboratories1985-04-03
NYTONE ENURETIC ALARM BEDWETTING DEVICE (K844866)Nytone Medical1985-04-03
SENTRY SIGNAL ENURESIS ALARM SYSTEM (K844636)Conklin Technology, Inc.1985-04-03
BED SENTRY, MODEL 50U (K850538)Metatech Corp.1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER (K851112)The Huxley Instrument Corp.1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR (K851113)The Huxley Instrument Corp.1985-04-03
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L (K850866)Erika, Inc.1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV (K851111)The Huxley Instrument Corp.1985-04-03
MUFFLER GAS-AIR VENT UNIT (K832170)Dr. Edward Richards1985-04-02
MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT (K844850)Medicorp, Inc.1985-04-02
DIAFLEX OCCLUSION BALLOON CATHETER (K850790)American Edwards Laboratories1985-03-25
TBI TRAINER (K840837)Manico1985-03-25
FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G (K850127)Computer Dialysis Systems, Inc.1985-03-20
AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (K850756)Travenol Laboratories, S.A.1985-03-20
ABBOTT INPERSOL CYCLER 1000 (K845042)Abbott Laboratories1985-03-19
IVAC KEOFEED II POLYURETHANE FEEDING TUBE (K850182)Y1985-03-19
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH (K844336)Vas-Cath of Canada , Ltd.1985-03-13
VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH (K844434)Vas-Cath of Canada , Ltd.1985-03-13
VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA (K844433)Vas-Cath of Canada , Ltd.1985-03-13
URETEROSCOPY CATHETER (K850335)Inmed Corp.1985-03-12
MENTOR PERCUTANEOUS RENAL DILATOR SET (K850355)Mentor Corp.1985-03-12
BSM 2000 DIALYSIS MACHINE - MODIFIED (K850569)Organon Teknika Corp.1985-03-12
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM (K844630)Organon Teknika Corp.1985-03-12
TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 (K850655)Erika, Inc.1985-03-07
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S (K850175)Mentor Corp.1985-03-07
TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID (K850654)Erika, Inc.1985-03-07
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM (K850298)Cabot Medical Corp.1985-03-05
MBM(TM) MONITRAL (R) BICARBONATE MODULE (K850179)Hospal Medical Corp.1985-02-28
COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 (K844993)Omnis Surgical, Inc.1985-02-28
GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY (K850285)Premium Plastics, Inc.1985-02-28
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL- (K850176)Mentor Corp.1985-02-28
RENAL BIOPSY TRAY (K850438)Packaging Technologies, Inc.1985-02-26
ATTENDS INCONTINENT UNDERGARMENT (K850611)Procter & Gamble Mfg. Co.1985-02-26
1URO-LOG HOME DIAGNOSTIC PACK (K844338)Epcom Medical Systems, Inc.1985-02-25
CAPD STAGED CONNECTOR (K845041)Abbott Laboratories1985-02-21
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM (K850406)Travenol Laboratories, S.A.1985-02-21
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD (K844750)Seratronics, Inc.1985-02-15
BILIARY STENT PROSTHESIS (K844384)Mentor Corp.1985-02-14
PEDIATRIC SIZE K-TUBE A OR B (K843939)Midwest Metabolic Support Group1985-02-14
KANGAROO NASOGASTRIC FEEDING TUBE (K843567)Chesebrough-Pond'S U.S.A. Co.1985-02-14
ESOPHOGEAL PH CATHETER (K850074)Biosearch Medical Products, Inc.1985-02-14
DIGNITY PANT & ABSORBENT PADS (K850154)Convatec, A Division of E.R. Squibb & Sons1985-02-14
ENTRON ENTERAL FEEDING BAG (K850134)Biosearch Medical Products, Inc.1985-02-14
FRESENIUS HAEMODIALYSIS ;MACHINE A1008 (K844641)Seratronics, Inc.1985-02-14
ADULT DISPOS. INCONTINENT PANTS (K850153)Convatec, A Division of E.R. Squibb & Sons1985-02-14
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (K842039)Argon Medical Corp.1985-01-29
NEPHROSS ALLEGRO H.F. (K844748)Organon Teknika Corp.1985-01-22
ESKA MULTISTAGE ESOPHAGEAL BOUGIE (K843186)Dacomed Corp.1985-01-18
ASAHI NEW PAN-SERIES HEMOFILTERS (K844663)Asahi Medical Co., Ltd.1985-01-18
SARTORIUS MINISART SM 16596HY (K844504)Sartorius Filters, Inc.1985-01-18
UNITED SKIN BARRIERS (K844938)Pfizer, Inc.1985-01-18
MODULAR FIBERSCOPE SYSTEM (K843683)Reichert Scientific Instruments1985-01-18
PEDIATRIC SIZED HEMOCATH CATHETER (K844692)Quinton, Inc.1985-01-18
UNITED SKIN BARRIER PASTE (K844341)Howmedica Corp.1985-01-18
STANDARD URINARY DRAINAGE BAG & LEG BAG (K844155)Norris W. Whitlock1985-01-16
ST FAMILY OF HOLLOW FIBER DIALYZERS (K844756)Travenol Laboratories, S.A.1985-01-16
DAVOL ERCP CANNULA (K845018)C.R. Bard, Inc.1985-01-15
CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (K845010)Chesebrough-Pond'S U.S.A. Co.1985-01-15
RIGID FIBEROPITC ENDOSCOPE (K844769)Microvasive1985-01-15
ULTRA EXTERNAL CATHETER (K844801)Inmed Corp.1985-01-15
OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE (K844143)Olympus Corp.1985-01-15
DAVOL POLYPECTOMY SNARE (K845016)C.R. Bard, Inc.1985-01-15
DAVOL RETRIEVAL BASKETS & FORCEPS (K845017)C.R. Bard, Inc.1985-01-15
DAVOL PAPILLITOME (K845015)C.R. Bard, Inc.1985-01-15
ENDONEEDLE (K844619)Endotherapeutics1985-01-09
HEMODIALYSATE SOLUTIONS (K843866)Bicarbolyte Corp.1985-01-09
EFF-EFFNER BULBS (K844773)Mecron Medical Products, Inc.1985-01-08
BARD URETEROSCOPIC CYTOLOGY BRUSH (K844561)C.R. Bard, Inc.1985-01-08
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM (K844684)Coloplast A/S1985-01-08
COLOPLAST URO 2002 UROSTOMY SYSTEM (K844685)Coloplast A/S1985-01-08
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE (K844343)Top Surgical Manufacturers Co.1985-01-08
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD (K843963)Renal Systems, Inc.1985-01-07
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM (K844108)Renal Systems, Inc.1985-01-07
K-TUBE (K844745)Midwest Metabolic Support Group1985-01-07
URINARY DRAINAGE CONTAINER 2012-WITH (K843441)Vital Metrics, Inc.1985-01-03
URINARY DRAINAGE CONTAINER 2013 WITH (K843442)Vital Metrics, Inc.1985-01-03
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE (K843084)Olympus Corp.1985-01-03
HOBBS MEDICAL POLYPECTOMY SNARE (K844074)Hobbs Medical, Inc.1985-01-03
HOBBS MEDICAL/JAYCO ASPIRATION CATHETER (K844550)Hobbs Medical, Inc.1985-01-03
MODIFIED C-DAK (K844185)Cd Medical, Inc.1985-01-03
HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT (K844551)Gobbs Medical, Inc.1985-01-03
FEMALE URINARY INCONTINENCE SYS (K843128)Chesebrough-Pond'S U.S.A. Co.1985-01-02
ENDOSCOPIC MANUAL AIR INSUFFLATOR (K844689)Jayco Pharmaceuticals1985-01-02
ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 (K844203)Exco, Inc.1985-01-02
ENDOSCOPIC ASPIRATION CATHETER SET (K844691)Jayco Pharmaceuticals1985-01-02
KANGAROO ACCESS II ENTERAL FEEDING CONTAINER (K844789)Chesebrough-Pond'S U.S.A. Co.1985-01-02
ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (K844690)Jayco Pharmaceuticals1985-01-02
ENTERNAL FEEDING TUBE-POLYURETHANE EF504 (K844175)Exco, Inc.1985-01-02
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK (K844503)Epcom Medical Systems, Inc.1985-01-02
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE (K844280)Travenol Laboratories, S.A.1984-12-17
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